AMSTERDAM, The Netherlands, August 25, 2011 /PRNewswire/ --
Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today reported its results for the first half year of 2011.
Highlights
- Glybera®:
- Data showing Glybera produces significant reduction in risk of pancreatitis in LPLD patients presented at European Atherosclerosis Society Meeting
- CHMP does not consider Glybera approvable at this time
- Chylomicrons now validated as biomarker for Glybera efficacy; data presented at American Society of Gene and Cell Therapy annual meeting
- AMT generating further chylomicron data from existing treated patients to support re-examination process
- Submitted for re-examination, outcome expected before end 2011
- Collaboration with Institut Pasteur-led Consortium to develop Sanfilippo B gene therapy product for cGMP manufactured material; worth up to 1.8 million to AMT
- 1.1 million funding for Acute Intermittent Porphyria gene therapy product as part of EU Consortium
- Grant from Dutch Parents Association for Duchenne Muscular Dystrophy gene therapy
- Appointment of Dr. Carlos R. Camozzi as Chief Medical Officer
- Key financial figures in line with guidance
- Cash & cash equivalents of 9.1 million at June 30, 2011, in line with budget
“We have moved quickly and have already filed an application for re-examination of Glybera, after the initial disappointment with the CHMP opinion in June. We are continuing to collect more data to show that there is a long-term reduction in the incidence of pancreatitis in treated patients. We will be able to generate the additional data required from the existing treated patients, and the data will come from a trial which we had already planned to do as a post-marketing study,” noted Jörn Aldag, CEO of Amsterdam Molecular Therapeutics. “AMT will also continue development of other gene therapy products in the company’s pipeline.”
